Suprofen API Manufacturer in India

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Suprofen API Manufacturer in India

Suprofen API

Suprofen is a non-steroidal anti-inflammatory drug (NSAID) active pharmaceutical ingredient (API) belonging to the arylpropionic acid class of anti-inflammatory compounds.

Suprofen has CAS Number 40828-46-4, molecular formula C₁₄H₁₂O₃S and molecular weight 260.31 g/mol. Its chemical name is 2-[4-(thiophene-2-carbonyl)phenyl]propanoic acid. It is also known as p-2-Thenoylhydratropic acid. (pubchem.ncbi.nlm.nih.gov)

Chemical and Pharmaceutical Profile

Suprofen contains a propionic acid moiety attached to a substituted phenyl group containing a thiophene carbonyl structure.

The API is generally characterized as a crystalline solid and can be identified using infrared and ultraviolet absorption techniques. Its pharmaceutical quality can be evaluated through HPLC assay, impurity testing, moisture determination and physical-property testing.

Suprofen has a molecular weight of 260.31 g/mol and is recognized as a non-narcotic analgesic and prostaglandin biosynthesis inhibitor. (ebi.ac.uk)

Pharmaceutical Applications

Suprofen is associated with anti-inflammatory and analgesic pharmaceutical applications. Its pharmacological activity is related to inhibition of prostaglandin biosynthesis through cyclooxygenase pathway inhibition.

The compound has been classified as a non-steroidal anti-inflammatory drug and non-narcotic analgesic. (ebi.ac.uk)

Suprofen has also been used in ophthalmic pharmaceutical applications, particularly in formulations where its anti-inflammatory activity is required.

Quality and Analytical Testing

Suprofen API can be evaluated using pharmacopoeial identity, HPLC assay, moisture, inorganic-residue, heavy-metal and impurity testing.

The USP monograph specifies Suprofen at 98.0–102.0% calculated on the dried basis. It also specifies loss on drying of not more than 0.5%, residue on ignition of not more than 0.2%, and heavy metals at not more than 0.002% (20 ppm). (drugfuture.com)

Typical analytical controls may include:

  • Infrared identification
  • UV absorption identification
  • HPLC assay
  • Related-substance / ordinary impurity testing
  • Loss on drying
  • Residue on ignition
  • Heavy-metal testing
  • Melting-range determination
  • Clarity of solution
  • Physical appearance and solubility evaluation

The USP HPLC assay uses a phosphate buffer/methanol mobile phase and UV detection as part of the chromatographic procedure. (drugfuture.com)

Suprofen API Manufacturer in India

Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing capabilities for Suprofen with quality-focused analytical evaluation and documentation.

Suprofen API can be handled according to applicable pharmacopoeial requirements and agreed customer specifications. Quality evaluation can cover identity, HPLC assay, impurities, moisture, inorganic residue and physical characteristics.

For pharmaceutical companies requiring Suprofen API from an India-based manufacturer, specification alignment, batch consistency, analytical testing and appropriate documentation are important considerations.

Packaging and Storage

Suprofen API should be stored in suitable, tightly closed pharmaceutical packaging that protects the material from contamination, moisture and excessive environmental exposure.

The USP monograph specifies preservation in well-closed containers. (drugfuture.com)

Recommended handling includes:

  • Store in a cool and dry environment.
  • Protect from excessive moisture.
  • Protect from direct light.
  • Keep containers tightly closed.
  • Use suitable pharmaceutical-grade packaging.
  • Follow the storage conditions defined in the applicable product specification.

Documentation

Depending on customer and regulatory requirements, documentation may include:

  • Certificate of Analysis (CoA)
  • Product specification
  • Safety Data Sheet (SDS)
  • Batch analytical data
  • Technical documentation
  • Packaging information
  • Stability documentation where applicable
  • Regulatory documentation as agreed with the customer

Why Choose Suprofen API from Swapnroop?

Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API manufacturing with quality systems, analytical evaluation and documentation intended to support pharmaceutical applications.

Suprofen API is handled according to defined quality requirements with attention to identity, assay, impurities, physical characteristics and batch-to-batch consistency.

Customers can discuss Suprofen API requirements, applicable specifications, packaging and documentation with Swapnroop Drugs and Pharmaceuticals.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.2%
Heavy Metals NMT 20 ppm
Melting Point 118–125°C
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